Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of mp-214 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the efficacy, safety, and tolerability of mp-214 relative to placebo in patients with acute exacerbation of schizophrenia.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from the patient before the initiation of any study-specific procedures * patients diagnosed with schizophrenia according to the diagnostic criteria of the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for schizophrenia * patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ecg) exclusion criteria: * patients with a dsm-iv-tr diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar i or ii disorder the information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: schizophrenia antipsychotic agents acute schizophrenia mental disorder psychotropic drugs dopamine agents risperidone central nervous system agents
this project aims to understand the needs of rheumatologists and other specialties in the care of patients with sle

Conditions: Systemic Lupus Erythematosus

Summary: the project will be conducted in four distinct stages. firstly, evidence synthesis will be carried out to gather and analyze available data on the topic. following this, a discussion among physicians will be facilitated to understand the knowledge gaps among rheumatologists and other specialists regarding sle. subsequently, consensus will be sought among a select group of rheumatologists on various aspects related to patient care, unmet medical needs, and implementation of new technologies. finally, the findings and conclusions from these stages will be used to inform the development and publication of scientific papers.

this study has as geral objective understanding the currently unmet development needs of rheumatologists and other specialists involved in the care of patients with sle, from a comparative perspective with other rheumatic diseases. the goal is to increase the engagement of these professionals in the discussion and management of patients and sécific objectives, compare the currently available evidence on sle and three other rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis); promote discussions to understand the knowledge development needs of rheumatologists regarding sle; generate a consensus on the equity of rheumatic diseases in relation to public policies, guidelines, registries, patient association mobilization, patient journey, time to diagnosis, and available medications with access to treatment and, promote awareness and knowledge through scientific publications about sle.

Eligibility criteria:
inclusion criteria: - all the patients with sle registered in datasus, in the outpatient system (sia) and in the hospital system (sih) from 2019 to 2022 exclusion criteria: * not applicable

Keywords: lupus rheumatologists arthritis spondylitis
effects of two dosing regimens of bosentan in children with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the primary objective of ac-052-373 was to assess the pharmacokinetic (pk) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (pah) \<12 years of age.


Eligibility criteria:
inclusion criteria: 1. pah diagnosis confirmed with right heart catheterization (rhc): * idiopathic or heritable pah, or * associated pah persisting after complete repair of a congenital heart defect (pah has to be persistent for at least 6 months after surgery) or * pah-congenital heart disease (pah-chd) associated with systemic-to-pulmonary shunts (after global amendment dated 09 may 2012) 2. world health organization functional class (who fc) i, ii or iii 3. male or female ≥ 3 months and \< 12 years of age (maximum age at randomization is 11.5 years) 4. body weight ≥ 3.5 kg 5. peripheral oxygen saturation (spo2) ≥ 88% (at rest, on room air) 6. baseline pah-therapy (calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-5 inhibitor) if present, has to be stable for at least 3 months prior to screening. during the study, all background treatments should remain stable 7. signed informed consent by the parents or legal representatives exclusion criteria: 1. pah etiologies other than listed above 2. non-stable disease status 3. need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost 4. systolic blood pressure \< 80% of the lower limit of normal range 5. aspartate aminotransferase and/or alanine aminotransferase values \> 1.5 times the upper limit of normal range. 6. moderate to severe hepatic impairment, i.e., child-pugh class b or c 7. hemoglobin and/or hematocrit levels \< 75% of the lower limit of normal range. 8. known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible tracleer tablet 9. treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest: * glibenclamide (glyburide) * cyclosporin a * sirolimus * tacrolimus * fluconazole * rifampicin (rifampin) * ritonavir * co-administration of cyp2c9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong cyp3a4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole) * endothelin receptor antagonists (eras) other than bosentan 10. treatment with another investigational drug within 1 month prior to randomization or planned treatment

Keywords: pulmonary arterial hypertension children pediatric bosentan
study of postprandial incretin response in women with gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: the researchers investigated nineteen pregnant women in third trimester and again postpartum. at the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (glp-1), glucose-dependent insulinotropic polypeptide (gip), insulin, c-peptide and glucagon. the researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial glp-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

the researchers investigated nineteen pregnant women in third trimester and again postpartum. at the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (glp-1), glucose-dependent insulinotropic polypeptide (gip), insulin, c-peptide and glucagon. the researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial glp-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Eligibility criteria:
inclusion criteria: * normal haemoblobin * willingness to participate exclusion criteria: * first degree relative with diabetes * diabetes before pregnancy * positive islet cell- and gad-65 autoantibodies

Keywords: gestational diabetes mellitus meal test incretin hormones glucagon-like peptide-1 (glp-1) glucose-dependent insulinotropic polypeptide insulin c-peptide glucagon
first in human, phase 1 study of ag013736 in patients with solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of the study was to characterize the safety of investigational agent ag-013736, in patients with solid tumors in this first in human trial.


Eligibility criteria:
inclusion criteria: * patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site * patients with adequate bone marrow, liver and kidney function * patients with life expectancy of at least 12 weeks exclusion criteria: * patients who have received chemotherapy, immunotherapy, radiotherapy or any investigational agent within 4 weeks of study entry * patients with have had a major surgical procedure within 4 weeks of study entry
canine-assisted anxiety reduction in emergency care iv

Conditions: Anxiety Acute; Chronic Pain

Summary: prior literature demonstrates that human stress can be reduced with exposure to animals. this study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. the objectives of this study are to determine if interaction with a certified therapy dog and handler can; * decrease reported anxiety levels in emergency department (ed) patients, * decrease salivary cortisol in ed patients, * decrease total morphine equivalent dosing in the emergency department or at discharge and/or, * decrease reported stress levels in emergency department providers caring for participating patients when compared to usual care.


Eligibility criteria:
inclusion criteria: patients * age 18-89 years * chronic pain, defined as pain on most days for \>6 weeks * triage pain score \>6 out of 10 or * age 18-89 years * currently experience crisis, including suicidality, or * meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the faces stress scale providers • faculty, residents, advanced practitioners, and nurses who work in the ed and identify themselves as being the nurse or physician of record for the enrolled patients. therapy dog handlers • handler of a certified therapy dog and volunteer of eskenazi's therapy dog program exclusion criteria: patients * violent behavior * overt intoxication * non-english speaking * any reported prior fear or adverse reaction to dogs providers • any reported prior fear or adverse reaction to dogs therapy dog handlers • none
the effect of pistachio-rich breakfast meals on cognitive function in healthy older adults

Conditions: Cognition

Summary: this study aims to investigate the effect of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on cognitive function throughout the course of the day in healthy ageing adults aged 65-80.

this crossover rct investigates the acute postprandial effect (over a 6-hour period) of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on the cognitive behaviour in healthy adults aged 65-80 years old. the study will also assess markers of inflammation and brain health by taking blood samples, and explore brain function (eeg) and blood flow (fmd) to understand how pistachio nuts may positively influence cognitive health. the study will involve a screening visit and four testing visits, with a week interval between each. on the evening prior to each test visit, participants are asked not to consume any food or drinks expect water, including tea/coffee and alcohol, after 8.30pm, and on the morning of test visits to only consume one slice of buttered white toast and a glass of water prior to attending the visit. during the four testing visits, cognitive and mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. blood draws are taken at the end of the day. for the subset of participants taking part in fmd, this will be measured at baseline, 2, 4 and 6 hours prior to cognitive testing. for those taking part in eeg, this data will be collected at 6 hours.

Eligibility criteria:
inclusion criteria: * 65 - 80 years old * fruit \& veg intake less than or equal to 4 servings per day * not regularly consuming more than 3 servings of fish per week * adequate english language and visual \& auditory acuity to perform the cognitive tasks * normal bmi for age * normal mmse performance between 26-30 exclusion criteria: * being diagnosed with psychological or psychiatric disorders * adhd or dyslexia * any food allergy or intolerance * use of medications and dietary supplements that may impact study results * antibiotic use within the last 3 months * adherence to vegan or vegetarian diets, or other specific diets that may impact study outcomes * being diagnosed with cardiometabolic disease (including type ii diabetes and cardiovascular disease), or suffer from untreated hypertension or thrombosis related disorders * taking blood thinners

Keywords: cognition pistachios vascular neural inflammation mood
etoposide in treating young patients with relapsed ependymoma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well etoposide works in treating young patients with ependymoma.

objectives: primary * determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide. secondary * determine the possibility of second surgery or additional radiotherapy in these patients. outline: this is a multicenter study. patients receive etoposide iv over 1 hour on days 1-3, 8-10, and 15-17. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients whose tumor becomes resectable after courses 3 or 6 undergo surgical resection. after completion of study treatment, patients are followed periodically for approximately 5 years. projected accrual: at least 14 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed intracranial ependymoma at first, second, or third relapse * anaplastic (malignant) or low-grade ependymoma (cellular, papillary, clear cell, or mixed variants) * unequivocal evidence of tumor recurrence or progression by mri scan after failing conventional treatment (e.g., primary surgery and adjuvant radiotherapy) for initial or recurrent disease * unresectable disease or not amenable to complete surgical resection * measurable enhancing or non-enhancing disease on baseline scan performed within the past 2 weeks * patients who have undergone prior surgery must have residual measurable disease patient characteristics: * lansky performance status 30-100% * life expectancy ≥ 8 weeks * absolute neutrophil count \> 1,000/mm\^3 * platelet count \> 100,000/mm\^3 * serum total bilirubin normal * ast \< 2 times upper limit of normal * no unrelated medical condition (e.g., renal or liver impairment) that would preclude chemotherapy treatment * no active infection * no known hiv positivity prior concurrent therapy: * see disease characteristics * no radiotherapy within the past 6 weeks * no chemotherapy within the past 4 weeks * prior iv etoposide allowed

Keywords: recurrent childhood ependymoma childhood infratentorial ependymoma childhood supratentorial ependymoma
telemonitoring of cpap therapy in apoplexy patients with osa

Conditions: OSA; Apoplexy

Summary: apoplexy patients with osa are often not receiving a cpap therapy due to generally poor acceptance and adherence. there is a great potential to significantly improve the treatment and care of these patients in a time economic way by telemonitoring the therapy in home environment. this study is planned to prove that telephone consultancy and motivation in times of recorded decreasing cpap therapy usage can improve adherence, neurological function and quality of life.

eligible patients with confirmed osa from neurological rehab department of helios clinic hagen ambrock are asked to join the study. they will be randomly assigned to one of two arms \[cpap with telemonitoring (mtm) or without telemonitoring (otm)\] for 6 months of home treatment after hospital discharge. the mtm arm will receive supporting phone calls when the monitored usage time decreases.

Eligibility criteria:
inclusion criteria: * s/p acm (arteria cerebri media insult) * diagnosed osa ahi \>15/h * barthel index item 8 \> 5 points (or home assistance) * life expectancy \>6 month * capable of giving consent exclusion criteria: * already existing ventilatory support (cpap, niv etc) * central ai \>50% baseline * central ai \>5/h under cpap therapy * drug abuse * pregnant or nursing women * participation in another clinical trial last 4 weeks

Keywords: osa apoplexy cpap adherence telemonitoring
phase iii rhu_gm-csf + 3 induction regimens in adults with acute non-lymphocytic leukemia

Conditions: Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia

Summary: phase iii study of priming with granulocyte-macrophage colony stimulating factor (rhu-gm-csf) and ofthree induction regimens in adult patients (over 55) with acute non-lymphocytic leukemia


Eligibility criteria:
inclusion criteria: * all patients with acute non-lymphocytic leukemia are eligible for the study. exclusion criteria: * n/a
comparison in efficacy and safety between interferon alfacon-1 alone and concomitant dosing with ribavirin for the treatment of hepatitis c

Conditions: Hepatitis C

Summary: efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of interferon alfacon-1 and ribavirin in hepatitis c patients.


Eligibility criteria:
inclusion criteria: * hepatitis c patients (high titer, genotype1) exclusion criteria: * patients with autoimmune disorder * patients with negative hbs antigen * patients with hepatic cirrhosis, hepatic failure and hepatic cancer * patients with depression or psychoneurotic disorder

Keywords: interferon alfacon-1 virus disease hepatitis c
a personalized nutrition intervention for adolescent depression

Conditions: Depression

Summary: this study is being done to test the feasibility of a personalized nutrition eating plan in adolescents with depression. evidence suggests that dietary quality may affect an individual's mood. a healthy diet includes vegetables, fruit, nuts, seeds, and olive oil, as well as minimally processed whole grains, legumes, and moderate amounts of lean meat, fish, and dairy. the investigators will examine the feasibility of a personalized nutrition eating plan for children and youth with depression. previous research has shown that it helps improve depressive symptoms in adults, but it is not clear if the same is true for children and youth.

the proposed 8-week, mixed-methods, single-arm study aims to examine the feasibility of an adjunctive personalized dietary intervention for adolescents with major depressive disorder. the secondary aims are to determine potential barriers and facilitators of implementation and to improve adherence and uptake.

Eligibility criteria:
inclusion criteria: * diagnosis of mdd as determined by semi-structured diagnostic interview * access to the internet and a computer or smart phone * presence of a parent who is willing to participate exclusion criteria: * adherent to a high-quality diet at baseline * presence of an eating disorder, as determined by semi-structured diagnostic interview * currently participating in other dietary programs or studies * actively attempting to increase or decrease body weight; * presence of a chronic medical condition; * unstable psychiatric condition (e.g., mania, active suicidal ideation)

Keywords: adolescents diet
intramuscular injection of mesenchymal stem cell for treatment of children with idiopathic dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: the main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(idcm); secondary end-points will be: 1)to explore the possible mechanism of the improvement of ventricular function in children with idcm and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.

children with idiopathic dilated cardiomyopathy class ii to iii nyha with ejection fraction over 20% were selected for phase ii clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.

Eligibility criteria:
inclusion criteria: * children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail. * they should have symptoms and /or signs of heart failure, despite optimized medical treatment. * ejection fraction of left ventricular should be less than 50%, but more than 20%. exclusion criteria: * associate coronary artery disease. * any history or suspicion of a toxic , pharmacologic or deposit etiology. * associated malignant or pre -malignant systemic disease. * associated hematologic disorder. * a history of sustained ventricular tachycardia or fibrillation. * a history of syncope during the previous year, or with an active infectious disease or positive tests to viral disease.

Keywords: dilated cardiomyopathy umbilical cord mesenchymal stem cells children
five-year observation of remicade treatment for plaque psoriasis in austria (study p04900)

Conditions: Psoriasis

Summary: prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of infliximab infusions for subjects with plaque psoriasis.

this study population was chosen from a non-probability sample.

Eligibility criteria:
inclusion criteria: * according to the european summary of product characteristics (spc): adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or psoralen-ultraviolet-a light (puva). exclusion criteria: * according to the european spc: * subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections. * subjects with moderate-to-severe heart failure (new york heart association (nyha) class iii/iv). * subjects with a history of hypersensitivity to infliximab or to other murine proteins or to any of the excipients. * subjects with elevated liver enzymes (\>5 upper limit of normal (uln)).